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- 2026-04-12 10:11:26
- Company
- Avodart leads 6th quarter
- by Kim, Jin-Gu Jun 08, 2022 05:56am
- Dutasteride are strong in the domestic hair loss treatment market. Both original and generic recorded higher sales growth than competitive drug Finasteride. According to IQVIA, a pharmaceutical market research firm, on the 2nd, GSK Avodart's sales in the first quarter were 10.7 billion won, up 9% from 9.9 billion won in the first quarter of last year. During the same period, Sales of Propecia fell 2% from 9.8 billion won to 9.7 billion won. The gap between Avodart and Propecia is 1.05 billion won, the largest since the second quarter of last year. Avodart, which was used as a treatment for prostate hypertrophy, has been in the shadow of Propecia for more than a decade since it began to be prescribed as a treatment for hair loss, adding indications in 2009. However, it has been maintaining its No. 1 position in the market for six consecutive quarters since it surpassed Propecia by a narrow margin in the fourth quarter of 2020. Quarterly sales of Propecia & Avodart ( Unit: 10 million won Data: IQVIA) In the case of generic, it was found that products with Dutasteride grew more than those of Finasteride. Total sales of Avodart's generics in the first quarter was 7.5 billion won, up 22% from 6.1 billion won in the first quarter of last year. During the same period, Propecia's generics increased only 9% from 12.3 billion won to 13.5 billion won. Sales of major generic products also reflected this trend Among generics for Propecia, sales of the u pharmaceutical's Momopecia increased 7% from 1.4 billion won to 1.6 billion won in a year, while JW's Monda and Genuonesciences's Mypecia fell 19% and 18%, respectively. In the case of generics for Avodart, Sales of Hanall Biopharma's Adamo tripled from 200 million won to 600 million won in a year. The pharmaceutical industry points to price competitiveness as one of the reasons for the increase or decrease in sales of major products. Recently, price competition has been fierce in the hair loss treatment market. Looking at the price supplied to the drugstore's online mall, the original product Propecia costs around 1,590 won. When THE U released Momopecia in 2020, it put a price tag of 600 won per tablet, which is less than half of the original. Momopecia has quickly grown into the highest-selling product among Propecia products with price competitiveness. As Momopecia grew rapidly, lower-priced products also appeared. In the second half of last year, DNBIO set a price of 350 won per 1mg dose t when it released Finaon. Other generic companies are said to have lowered prices one after another. As low-priced products grew around Momopecia, sales of existing high-end generic products such as Original Propecia and Monad (1,320 won) and Mypecia (960 won) naturally decreased. It is explained that Sales growth of Avodart is also related to price. Avodart is currently supplying 0.5mg dose at around 700 won. As the patent expired in 2016, Avodart lowered the existing drug price from 1,300 won to 920 won. In 2017, it was further reduced to 700 won, adding half the price tag compared to Propecia.
- Company
- Sales of Nexavar fell sharply
- by Jun 08, 2022 05:55am
- Sales of Nexavar, which has dominated the primary treatment market for liver cancer for 10 years, are falling. This is because prices have fallen due to the release of generic products, and the status of the first treatment for liver cancer as a new drug has been shaken. Compared to two years ago, quarterly sales have halved. ◆Tecentriq with Lenvima 1Q Sales Half According to IQVIA, a pharmaceutical research agency, on the 30th, Lenvima recorded 2 billion won in sales in the first quarter. The figure is down 41.2% from 3.4 billion won a year earlier. Nexavar's sales have been falling for seven consecutive quarters since the second quarter of 2020. Compared to two years ago, quarterly sales fell more than half from 5.1 billion won to 2 billion won. With the advent of competitive drugs, sales of Nexavar began to decline. It is Lenvima, a new drug for liver cancer treatment that appeared in 10 years. Lenvima, which is used as the first treatment for liver cancer along with Nexavar, narrowed the gap with Nexavar and succeeded in reversing the first quarter of 2021. Lenvima posted 4 billion won in sales in the last quarter, up 17.6% from the same period last year. Nexavar is the first targeted treatment to appear in the market for liver cancer treatments that are difficult to develop. It has been firmly established as the only liver cancer treatment for more than a decade. Annual sales amounted to 26 billion won. Nexavar began to falter with the launch of Lenvima. Initially, sales of Nexavar were overwhelming due to the strength of sequential treatment leading to Nexavar-Stivarga. However, Lenvima slowly boosted its influence with improved data. In October 2019, benefits were applied as the first treatment and settled in the 3 billion won in quarterly sales. ◆ Competitive drugs are emerging one after another Recently, the decline in Nexavar sales has become steeper with the emergence of generics. The government cut Nexavar's insurance cap by 30% in February last year. The move comes after Hanmi Pharmaceutical, which overcame Nexavar's patent, launched generics. Accordingly, the upper limit of Nexavar insurance fell from 18,560 won to 12,992 won. Nexavar Immediately after the weak cut was applied, quarterly sales of Nexavar fell 32% from the previous quarter, and were affected by the cut. Since then, Nexavar has continued its quarterly sales of 2 billion won. generic for Nexavar, released by Hanmi Pharmaceutical, posted sales of more than 400 million won in the first quarter, the fifth quarter of its release. Recently, as a new primary benefit option, it is a combination of Tecentriq, an immuno-cancer drug with a completely different mechanism from Nexava, and Avastin, an anti-VEGF treatment. Tecentriq+ Avastin combination therapy predicted a sensation from the first data release. This is because the reaction rate was more than twice that of Nexavar, and the significantly improved OS and PFS were recorded. Tecentriq combined therapy has already begun to exert influence by expanding its indications as the first treatment for hepatocellular carcinoma in July 2020. Starting this month, the impact is expected to increase further as benefits will be applied to the first treatment. Although there are still no drugs that can be used after Tecentriq therapy, it is predicted that the paradigm of primary treatment, which mainly used Nexavar or Lenvima, will change to Tecentriq therapy.
- Policy
- The price gap between Memantine products is more than 2.5x
- by Lee, Tak-Sun Jun 07, 2022 06:04am
- Original for Memantine HCl The price difference between Memantine producst was more than 2.5 times. This is because if there are more than 20 generics depending on the price calculation formula, new products are listed at 85% of the lowest price. Memantine preparations have originally had a large price gap between products, but the gap is widening according to this price calculation formula. According to the industry on the 6th, Ibixa (Memantine HCl) of I-World Pharmaceutical was listed at 334 won on the 1st, which is 85% of the lowest price of the listed same product, as more than 20 products are listed. Before Ibixa's registration, 64 Memantine HCl 10mg preparations were registered, and the lowest price was 393 won for Dongkook Pharmaceutical's Mmentine 10mg. Accordingly, Ibixa was registered at 334, which is 85% of 393 won. Since there are more than 20 generics, the drug price will fall again to 85% of the lowest price if the next product is listed. With the registration of Ibixa, the gap between the highest and lowest prices of Memantine products is more than 2.5 times. The highest price is 845 won. The original for Memantine, Ebixa, costs 803 won. In particular, the price difference between the same drugs is widening in dementia treatments. Donepezil tablet 5mg has quadrupled the price difference between the same drugs. It is analyzed that this is due to the specificity of the dementia treatment market. This is because the market size is large and competition is fierce, but it is not easy to enter customers. Regardless of the price difference, this market has high confidence in patients and medical staff for the original. In addition, because the prescription rate of nursing hospitals that are difficult to access (CSO) is high, the lowest-priced products targeting this are also emerging. An official from the pharmaceutical industry said, "The price strategy of dementia treatments takes into account the specificity of Rx." He explained, "In the case of low-priced drugs, there are preferred medical staff because they are not burdensome to use with other drugs, and it seems that they were aiming for the demand to purchase high-priced drugs at low prices and receive incentives." Analysts say that the price difference does not have a significant impact on patients because patient copy of dementia patients is small. However, the industry reports that such a price difference occurs because the preferences of doctors are different.
- Company
- Neutropenia drugs' sales affected by their sales partners
- by Chon, Seung-Hyun Jun 07, 2022 06:04am
- GC Pharma and Kyowa Kirin are fiercely competing for the lead in the neutropenia treatment market in Korea. At the end of last year, GC Pharma’s Neulapeg had risen to the lead for the first time in 7 years, but Kyowa Kirin has again taken over the lead with Neulasta. The addition of Boryung’s sales power to the products is affecting the sales rank of the two drugs in Korea. According to the pharmaceutical market research institution IQVIQ, Neulasta sold the most and raised ₩6.5 billion in sales in the neutropenia treatment market in Q1 this year. Rising 4.9% YoY, Neulasta took back the lead that it had lost to Neulapeg in Q4 last year. Neutropenia treatments prevent cancer patients from developing the side effect of a weakened immune system due to decreased neutrophil levels when they receive anticancer therapies. Neutrophils are a type of white blood cell that fight infections from bacteria, etc. Neulasta, a pegfilgrastim ingredient drug that was approved in 2012 in Korea is a second-generation neutropenia treatment. Neulapeg’s rising sales have been challenging the lead held by Neulasta in the neutropenia treatment market. Neulapeg is a neutropenia treatment made with pegteograstim and is indicated for ‘the reduction of the duration of neutropenia in patients treated to eliminate solid tumor and malignant lymphoma with cytotoxic chemotherapy.’ Neulapeg is the first biologic anticancer therapy that was developed with GC Pharma’s original technology Neulapeg had little commercial success in the early days of its release. Sales in 2017 and 2018 were only ₩3.2 billion and ₩4 billion, respectively. Most of its quarterly sales had been less than ₩1 billion. However, its sales started to rise steeply with the addition of Boryung’s sales power GC Pharma had signed a joint sales agreement with Boryung in October 2018 to expand the share of Neulapeg by using the sales power held by Boryung Pharmaceutical in the field of anticancer drugs. In Q1 2019, immediately after Boryung’s addition, Neulapeg accumulated sales of ₩1.3 billion and made a new quarterly sales record. Since then, the drug has continued on its rise to record ₩6.3 billion in sales in Q4 last year. Sales had increased sevenfold in only 3 years from the ₩0.9 billion in Q3 2018 before Boryung’s addition to take over the lead product in the market. This change in market demographics is analyzed to be greatly influenced by the switching of sales partners of Neulasta and Neulapeg recently. Boryung, which had driven the rapid growth of Neulapeg, has been selling Neulasta from the start of this year. Boryung had contributed to Neulapeg’s rise to the top at the end of last year, and to Neulasta’s takeover of the lead again this year. In place of Boryung, Jeil Pharmaceutical has been selling Neulapeg as GC Cross’s partner. The company has experience selling Neulasta from 2014 to 2017.
- Company
- Emgality passes DREC review… what about Ajovy?
- by Eo, Yun-Ho Jun 07, 2022 06:04am
- With Emgality nearing insurance reimbursement in Korea, what path Ajovy will walk is also gaining attention. Teva-Handok Pharma had applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab) earlier this year. However, Ajovy’s reimbursement was not deliberated as an agenda at the DREC meeting that was held in May this year, the same meeting at which Emgality (galcanezumab) passed deliberations. The gap could be reasonable when considering Emgality applied for reimbursement in March last year, but as the reimbursement discussion period for the two drugs had coincided somewhat, the industry had predicted that the two agendas will be deliberated at the same time, but saw different results. As a result, the company is awaiting DREC deliberation on the reimbursement of Ajovy and is in discussion with the HIRA. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their individual characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 47.7% in the monthly Ajovy and 44.4% in the quarterly Ajovy group, compared to the 27.9% in the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
- Policy
- Price Negotiation for One-shot Treatment Zolgensma
- by Lee, Tak-Sun Jun 07, 2022 06:04am
- Zolgensma of Novartis, which passed the Drug Reimbursment Evaluation Committee of the HIRA on the 12th of last month, began negotiations on drug prices to register health insurance benefits. Given that Kymriah of the same company, which has attracted attention as a once-in-a-lifetime drug, succeeded in being reimbursed two months after passing the Drug Reimbursment Evaluation Committee, attention is being paid to whether Kymriah will be able to proceed quickly. According to the industry on the 3rd, the NHIS and Korea Novartis will start negotiations on the drug price for the SMA treatment Zolgensma on the 25th of last month and proceed for two months until the 25th of next month. Earlier on the 12th of last month, Zolgensma was recognized as a condition for pre-approval of medical care benefits and application of RSA and caps based on patient performance at the Drug Reimbursement Evaluation Committee. Zolgensma is an ultra-high-priced drug sold in the U.S. for about 2.5 billion won, and it is urgent to register health insurance benefits for patients to relieve their economic burden and receive medication. There are many opinions asking for registration in that most of the patients with SMA, a rare disease, are children. The political community has welcomed the passage of the Drug Reimbursment Evaluation Committee. Choi Hye-young, a member of the Democratic Party of Korea, posted an SNS post titled "We are happy that it passed the Drug Reimbursment Evaluation Committee for SMA treatment," and Lee Jong-sung also said, "The adequacy of health insurance benefits for Zolgensma was recognized at the first review of the Yoon Seok-yeol government." "It is a decision that fits the policy philosophy of the Yoon Seok-yeol government to further protect the people in need," he welcomed. Zolgensma is compared to Kymriah, which previously succeeded in reimbursement for it, in that it is administered once in a lifetime and sold by Novartis. With the registration of Kymriah health insurance, it can be administered at up to 5.98 million won. As political circles and patient groups are paying keen attention, attention is being reimbursed to whether Zolgensma will succeed in making reimbursement as fast as Kymriah. If the drug price is settled within the negotiation period, health insurance benefits will also be available from August 1. As ultra-high-priced drugs appear one after another, health insurance finances are expected to be burdened by rising drug costs. Therefore, it is highly likely to affect the pharmaceutical industry depending on what position the Yoon Seok-yeol administration, which has just started, takes on the issue of drug cost management. Some analysts say that there is a possibility that generic drugs may be considered to be lowered due to the influence of the ultra-high-priced new drug registration.
- Company
- Cumulative sales of Spinraza in 3yrs is ₩200 billion
- by Chon, Seung-Hyun Jun 07, 2022 06:03am
- Spinraza, a rare disease treatment, posted 200 billion won in sales over the past three years after registering health insurance benefits. Although there is not much demand, it has achieved high performance in a short period of time due to the nature of expensive treatments worth nearly 100 million won per bottle. According to IQVIA, a pharmaceutical research firm, on the 3rd, Biogen's Spinraza sold 17.4 billion won in the first quarter, up 18.3% from the same period last year. Although it is less than 20.2 billion won posted in the first quarter of 2020, it has recorded 10 billion won in quarterly sales for three years since the second quarter of 2019. Quarterly Spinraza Revenue (Unit: 100 million won, Data: IQVIA) Spinraza is a rare disease treatment called SMA that treats neuromuscular genetic diseases in which muscles contract due to damage to spinal cord and brainstem motor neurons. SMA is a disease that has normal cognitive functions, but it is difficult to live a normal life, such as low muscle tension and contraction of tongue muscles. Spinraza, which received domestic permission in December 2017, was listed at an upper limit of 92.35 million won per bottle (5 ml) in April 2019 after negotiating the price of drugs with the NHIS. Spinraza made 10.2 billion won in sales in the second quarter of 2019 when it was listed on the health insurance benefit list. It recorded sales of 20.4 billion won and 15.9 billion won in the third and fourth quarters of 2019, respectively, and sold 46.4 billion won in the first year of the registration. Spinraza recorded sales of 10 billion won to 20 billion won in the quarter, showing sales of 72 billion won and 61.3 billion won in 2020 and last year, respectively. The cumulative sales raised after the registration totaled 7.1 billion won. Based on the high price of nearly 100 million won per bottle, it made a lot of sales in a short period of time. The size of the market has not expanded significantly because the number of patients is not large and a difficult procedure that requires prior review before administration.
- Company
- Bio USA to be held offline for the first time in 3 years
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- The Bio International Convention (BIO USA),’ which is known as one of the largest global events in the biotechnology industry, is set to be held in San Diego USA from the 13th to the 16th of this month. Twenty or more pharma and bio companies in Korea including Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics are planning to attend this first offline event held in 3 years since 2019. According to industry sources on the 3rd, over 3,000 companies have registered to attend Bio USA online and offline. Bio USA is a global bio event that is being held for the 29th time this year. After 2019's event that was held in Philadelphia, the event was held online for two consecutive years. This year will mark the first event that will be held offline in 3 years. In particular, 20 domestic pharmaceutical companies have expressed their will to physically attend the event. Samsung Biologics, Celltrion, SK Pharmteco, and Lotte Biologics have prepared separate booths to interact with other pharma-bio companies around the world. Also, the Korean booth that will be jointly operated by Korea BIO and KOTRA will make known the names of 16 other domestic companies. One company that is receiving particular interest is Lotte Biologics. Lotte had announced its plan to enter the bio business at the group level. The company acquired BMS’s manufacturing facility which is located in Eastern New York for $160 million (approx. ₩200 billion). Also, the company had set the goal to grow Lotte Biologics into one of the Top 10 global CDMO companies by investing ₩2.5 trillion over the next 10 years. The Bio USA is expected to be Lotte Biologics’s official debut in the global market. Lotte Biologics has secured an exclusive booth in the 'Contract Services Zone.’ Based on the manufacturing capability secured with the BMS plant, the company plans to make its name known to pharma and bio companies around the world at the event. Locations of Korean companies/organizations at BIo USA this year SK Pharmteco plans to participate in the event Yposkesi that it acquired last year. The Korean investment firm SK Holdings acquired the French gene and cell therapy CMO Yposkesi in March last year. The financial terms of the deal were not disclosed under agreement by both parties. In June last year, the company had additionally invited €58 million (approx. ₩80 billion ) to build a second plant. The second plant is expected to be completed by 2023 at a 5,000㎡ scale. If completed, the company will own the largest manufacturing capacity in Europe at a 10,000㎡scale. SK had also acquired BMS’s Ireland Swords plant in 2017 and US AMPAC in 2018. In 2019, the company had then established SK Pharmteco as an integrated CMO corporation. Samsung Biologics and Celltrion, regulars at Bio USA had also secured exclusive booths at the event. As the first offline event to be held in three years, the two companies are known to have high expectations for the event. Samsung Biologics’ CEO John Rim is expected to personally attend the event. Samsung Biologics has been recognized for its CMO capability in the global market during the past two years in the prolonged COVID-19 crisis. Samsung Biologics had decided to operate its own booth at Bio USA. Pic: 2019 Bio USA Other bio companies have also shown high expectations for this year’s event. Vigencell plans to attend this year’s event to have partnering meetings with various global companies. During the conference, it had made plans to have meetings with various companies and promote its ▲ViMedier ™(VM), the world’s first cord blood-derived myeloid suppressor cell therapy, ▲ViRanger ™(VR), the “Off-the-Shelf” allogenic universal T cell gene therapy, and ▲ViTier ™(VT), an antigen-specific killer T cell therapy. Bridge Bio Therapeutics has received an opportunity to introduce its company face-to-face for 13 minutes in front of industry officials at the ‘Company Presentation Theater 3’ on the morning 16th (local time), the last day of the event. The company plans to introduce its main development projects such as its targeted therapy candidates in its anticancer pipeline, 'BBT-176', 'BBT-207,’ as well as its ulcerative colitis treatment candidate 'BBT-401,’ idiopathic pulmonary fibrosis treatment candidate ‘BBT-877.’ Korea Bio and KOTRA which are supporting this year’s event explained that global interest in Korean companies has increased compared to the past. An official from Korea Bio said, “We have been receiving continued requests for partnership with Korean companies. Some have specifically requested to meet with certain companies, and some have asked us for recommendations.” He added, “Overseas companies have been more actively making requests, especially on vaccines or treatments.”
- Company
- Pharmas succeed in additionally avoiding Entresto patent
- by Kim, Jin-Gu Jun 03, 2022 06:37am
- Domestic pharmaceutical companies have succeeded in additionally avoiding the patent of Novartis’s heart failure treatment ‘Entresto.’ According to industry sources on the 2nd, the Intellectual Property Trial and Appeal Board recently ruled that the claims were established in the trial to confirm the passive scope of rights on Entresto’s substance patent (10-1700062) that Hanmi Pharmaceuticals filed against Novartis. In May last year, 10 companies in addition to Hanmi Pharmaceutical – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, Elyson Pharm – filed the same claims on this patent that is set to expire in 2028. Among these, the decision on Hanmi Pharmaceutical’s trial was the first to be made, and the results of other companies are also expected to be released soon. The Intellectual Property Trial and Appeal Board had also ruled in favor of the generic companies in a trial to confirm the passive scope of rights filed on Entresto’s another substance patent(10-1589317) that is set to expire in 2029 that Hanmi Pharmaceutical and Daewoong Pharmaceuticals had filed. The 10 companies – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, and Elyson Pharm – are also challenging the patent, results of which are expected to come out soon. Generic companies have also succeeded in avoiding Entresto’s crystalline patent. At the time, 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang succeeded in avoiding this patent that is set to expire in 2027. Currently, the issue is being tried at the Patent Court of Korea after Novartis’ appeal. Entresto is protected with a total of 5 (including 1 non-listed) patents. The patents are ▲salt and hydrates patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Among the 5 patents, generic companies have now overcome 3 patents, the ▲crystalline patent set to expire in September 2027, ▲the composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029. Only two patents, ▲the salt and hydrates patent that expires in November 2026 and the ▲use patent that expires in July 2027 are now left to be challenged. If the generic companies succeed in overcoming the remaining patents, they will qualify for early generic release. Entresto's PMS already expired in April. The key is likely to be the use patent that is set to expire in July 2027. Entresto is a combination drug of valsartan and sacubitril and has no separate substance patent. Therefore, the two patents on the ingredients act as substance patents. Entresto is Novartis’ heart failure treatment that was launched in October 2017 in Korea. According to the market research institution UBIST, outpatient prescription sales of Entresto have been rapidly increasing in size after recording ₩6.3 billion in 2018. Its sales recorded ₩32.3 billion last year.
- Company
- 10 years since stem cell therapy was introduced
- by Chon, Seung-Hyun Jun 03, 2022 06:36am
- 4 types of domestic approved stem cell therapyTen years have passed since stem cell treatments appeared in Korea, but they have yet to produce commercial results. Medipost's CARTISTEM is recording annual sales of 10 billion won in Korea, but there is virtually no overseas sales. According to the Financial Supervisory Service on the 2nd, Medipost's sales of stem cell treatments in the first quarter were 4.5 billion won, up 3.5% from a year earlier. Medipost's stem cell therapy is the only treatment for osteoarthritis, CARTISTEM. CARTISTEM is a drug mainly composed of stem cells derived from cord blood of the same kind. Medipost succeeded in developing the world's first cord blood-derived stem cell therapy using cord blood stem cells from others, and received an item approval from the MFDS in January 2012. It is used for the treatment of knee cartilage defects in ICRS grade IV. After surpassing 10 billion won in sales for the first time in 2017, CARTISTEM posted 10 billion won in sales for five consecutive years until last year. Last year, CARTISTEM's sales reached 17.2 billion won. However, the recent growth has slowed down somewhat. CARTISTEM's sales grew 36.1% and 16.6% year-on-year in 2018 and 2019, respectively, but in 2020 and 2021, they increased only 3.2% and 3.8% year-on-year, respectively. Looking at sales in the first quarter, CARTISTEM increased 95.1% and 40.1% year-on-year in the first quarter of 2018 and 2019. However, CARTISTEM's sales in the first quarter of 2020 and 2021 grew less than 1% year-on-year and recorded 3% growth this year. Medipost is seeking to enter the global market of CARTISTEM, but no overseas sales have occurred yet. The sales performance of other stem cell treatments other than CARTISTEM is even lower than expected. Currently, there are a total of four types of stem cell treatments approved in Korea. After Pharmicell's acute myocardial infarction treatment Hearticellgram-AMI was approved in Korea as the world's first stem cell treatment in 2011, CARTISTEM and Antrogen's Crohnistem were approved for market in 2012, and CORESTEM's Lou Gehrig's fourth stem cell treatment in 2014. In the first quarter of last year, Pharmicell's bio business sales were only 572 million won. Pharmicell's bio business includes cosmetics along with Hearticellgram-AMI. Last year, Pharmicell's bio business sales were only 800 million won. Cupistem posted 700 million won in sales in 2020, including stem cell culture. It recorded 359 million won in sales in the first quarter of last year. Antrogen has not disclosed sales by business units since the second quarter of last year. Total sales of anthrogen in the first quarter were 1.7 billion won. CORESTEM's Neuronata recorded sales of 1.9 billion won and 1.2 billion won, respectively, in 2020 and last year. It made 300 million won in sales in the first quarter. Although it received great attention at the time of domestic approval, it is not in high demand due to the characteristics of rare diseases, and its preference is rarely increasing at the prescription site. Stem cell therapy was once in the spotlight as a next-generation growth engine, but news of the recent emergence of new products is also far from clear. Since Neuronata's approval in 2014, there are no stem cell treatments approved for eight years. In 2016, the Ministry of Food and Drug Safety revised the regulations for product licensing screening such as biological drugs, allowing cell therapy used for life-threatening diseases or severe irreversible diseases to receive conditional approval only with the results of phase 2 clinical trials. The intention is to shorten the time to enter the market for cell therapy products whose safety has been confirmed and treatment effects have been searched. A life-threatening disease is a disease that is likely to die if it is not accompanied by appropriate treatment and is defined as a disease in which there is no alternative to treatment. Serious irreversible disease refers to a disease or condition in which irreversible pathological conditions deteriorate for functions necessary for daily life if appropriate treatment is not accompanied. After easing regulations on cell therapy approval, bio companies such as Kang Stem Biotech, Naturecell, and Pharmicell attempted conditional approval of stem cell treatments, but all failed.
